Recruiting

Laser & Anti-VEGF

Sponsor:

University of Toronto

Code:

NCT01196325

Conditions

Diabetic Macular Edema

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Accepted

Study Details

Brief summary:

The study will investigate changes in the structure and function of blood vessels in the front and back of the eye following laser and anti-VEGF treatments for sight-threatening diabetic eye disease. Sixty four volunteers will be recruited, including age-matched control subjects and diabetic patients who require conventional or contemporary treatment for pre-existing diabetic eye disease. Volunteers will be assessed before and after treatment using state-of-the-art techniques to measure vision, the rate of blood flow and structure at the front and back of the eye and the effectiveness of blood flow delivery. Changes following treatment in these novel, non-invasive techniques will be quantified and described. We anticipate that conventional and new / developing treatments will lead to narrowing of the vessels and consequent reduction of blood flow at the back and front of the eye. There will be a strong relationship between structural changes of the eye and functional changes of blood vessels at the front and back of the eye. The results of this study will improve our understanding of the impact of the various treatments on the entire eye. The research will also ensure an improved understanding of the mechanisms of action of the various treatments and will provide insight of reasons for good or poor outcomes, based upon specific changes in structure and blood flow.

Conditions

Diabetic Macular Edema

Study ID

NCT01196325

Start date

Jul, 2009

Status verified date

Jan, 2013

Completion date

Aug, 2014

Anticipated

Primary completion date

Aug, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age range of 35-75 yrs
  • Type 2 diabetes apart from age-matched control group
  • Visual acuity of 20/400 or better
  • Confirmed diagnose of Clinical Significant Diabetic Macular Edema (applies for Diabetic Groups only)
  • Previously untreated eye for retinal diseases and disorders

Exclusion Criteria:

  • Distance refractive error > ± 6.00 DS \& / or ± 2.50 DC
  • Intraocular pressure ≥ 22mm Hg
  • Proliferative Diabetic Retinopathy
  • Any other active eye disease and disorder
  • Participants with history of cardiovascular events, stroke, thromboembolic events, transient ischemic attack, uncontrolled hypertension.
  • Any active ocular infection;
  • History of glaucoma;
  • Known allergy, hypersensitivity or contraindication to the study medication;
  • Pregnancy, breast feeding, or women of childbearing potential who are not using a reliable method of contraception;
  • Proteinuria and/or renal impairment;
  • Surgery within the past 28 days.

Study Design

Enrollment

64 participants

Anticipated

Interventions and Outcome Measures

Arms

Laser Group

Patients who are clinically indicated for the laser treatment

Anti-VEGF Group (Bevacizumab)

Patients who are clinically indicated for the intravitreal injection of Bevacizumab

Anti-VEGF Group (Ranibizumab)

Patients who are clinically indicated for intravitreal injection of Ranibizumab

Age-matched controls

Group of non-diabetic participants who will be age and gender matched

Primary outcome measure

  • Quantitative inner retinal blood flow [ Time Frame: Baseline, 3, 7, 30 days and 3 months ]

Central Contacts and Locations

Central contacts

Locations

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T2S8

Contacts

Principal Investigator:

Christopher Hudson, PhD

More Information

Sponsor

University of Toronto

Last update posted

Jan 24, 2013

Last verified

Jan, 2013

Keywords

  • Diabetes
  • Diabetic Macular Edema
  • Laser
  • Anti-VEGF
  • Morphology
  • Blood Flow
  • Vision

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Toronto on 2013-01-24.